Mitochondrial Replacement Techniques for Infertility: How Legal Barriers Harm Patients and Children

Recent studies show that mitochondrial replacement techniques (“MRTs”) can help women with poor egg quality and repeated IVF failures get pregnant and deliver healthy children. Unfortunately, infertile Americans can derive no hope from this promising development. The U.S. Food and Drug Administration (“FDA”) claims jurisdiction over novel assisted reproductive technologies. Fertility clinics and doctors who want to provide MRTs must submit an investigational new drug (“IND”) application to the FDA and wait for approval before proceeding with clinical trials.

However, for the past decade, Congress has enacted an annual appropriations rider that precludes the FDA from acknowledging receipt of applications for such clinical trials. In other words, although the FDA claims jurisdiction over MRTs, it cannot act, so patients have no chance to gain access. This regulatory failure will drive infertile Americans to pursue MRTs in foreign countries. Congress may react by enacting new legislation to criminalize MRTs at home or abroad.

However, no criminal law achieves its objectives entirely. This Article anticipates that some patients will travel in defiance of such a ban, conceiving children who will be born and raised in the United States. If caught, some patients will be sent to prison for unauthorized procreation and their children will be stigmatized as unworthy to exist. This Article concludes that Congress should not enact a ban.

Instead, Congress should lift the rider and allow the FDA to receive applications for clinical trials of MRTs.